Interventional Study of Wellbutrin XL in Major Depressive Disorder With Atypical Features
- Registration Number
- NCT01477931
- Lead Sponsor
- Chi-Un Pae
- Brief Summary
The aims of this study are 1) to examine the clinical utility of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with Major Depressive Disorder (MDD) with atypical features; 2) to evaluate the tolerability of bupropion hydrochloride extended release (Wellbutrin XL®) in patients with MDD with atypical features.
- Detailed Description
Whether bupropion hydrochloride extended release (Wellbutrin XL®) improved atypical depressive symptoms has not been investigated. The investigators assumed that bupropion hydrochloride extended release (Wellbutrin XL®) will be effective and tolerable in the treatment of atypical depression in MDD patients.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- Age over 20 years
- DSM-IV episode of MDD non-psychotic with atypical features characterized by mood reactivity and 2 or more symptoms of vegetative reversal (including overeating, oversleeping, severe fatigue or leaden paralysis, and a history of rejection sensitivity)
- More than 19 score on the 29-item HAM-D
- Ability to give informed consent
- Bipolar depression
- Any Axis I psychotic disorder
- A history of suicide attempt, self-injurious action (excluding action with no intention of suicide) or overdosage (excluding apparently accidental overdosage)
- Patients with more than 3-point score of suicide (HAM-D-29 Item 18) or patients whose C-SSRS assessment suggests that they are or have been at significant risk for harming themselves or have actually harmed themselves, or who, in the opinion of the investigator (sub-investigator), are at significant risk for harming self or others
- A history of substance abuse in the previous 12 months
- A history of hypersensitivity to bupropion or any other components of the preparations used in the study (Wellbutrin SR 150mg and Wellbutrin XL 300 mg tablets)
- Serious or unstable medical disorders
- Starting or terminating psychotherapy during the previous 12 weeks,
- ECT treatment in the previous 3 months
- Subject has a life time diagnosis of anorexia nervosa or bulimia within the past 12 month
- Subject has a current or history of seizure disorder or brain injury (traumatic or disease-related) or any condition which predisposes to seizure- subject treated with other medications or treatment regimens that lower seizure threshold- subject undergoing abrupt discontinuation of alcohol or sedatives
- Subjects that previously failed adequate courses of pharmacotherapy from two different classes of antidepressants or previous adequate course(s) of bupropion
- Pregnancy or planning pregnancy - when a patient is in active reproductive age, he or she has to agree to use relevant contraception during the study
- Patients on monoamine oxidase inhibitors (MAOIs)
- Patients being treated with any other preparations containing bupropion as the incidence of seizures is dose dependent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Wellbutrin XL Bupropion extended release -
- Primary Outcome Measures
Name Time Method HAM-D-29 scores(Hamilton Depression Rating Scale 29) 8 weeks Changes in HAM-D-29 scores from baseline to the end of treatment.
- Secondary Outcome Measures
Name Time Method 8-atypical items on the HAM-D-29 8 weeks 8-atypical items on the HAM-D-29 from baseline to end of treatment.
Tolerability 8 weeks Tolerability evaluations will be determined by TEAEs(treatment-emergent adverse events) and vital signs recording.
CGI-I score(Clinical Global Impression Improvement score) 8 weeks CGI-I score of 1 or 2 (proportion of the patients achieving this point at the end of treatment) or changes in total scores on CGI-S
SDS(Zung Self-Rating Depression Scale) 8 weeks Change of SDS from baseline to end of treatment.
C-SSRS(The Columbia-Suicide Severity Rating Scale, changes in behaviours and ideation) 8 weeks Change of C-SSRS from baseline to end of treatment.
ESQ(Epworth Sleepiness Questionnaire) 8 weeks Change of ESQ from baseline to end of treatment.
Response 8 weeks Response will be defined as 50% or greater reduction in HAM-D-29 scores from baseline to end of treatment.
Remission 8 weeks Remission will be defined as a HAM-D-29 score of ≤ 7.
Trial Locations
- Locations (6)
Korea University Ansan Hospital
🇰🇷Ansan, Gyeonggi-Do, Korea, Republic of
Bucheon St.Mary's Hospital
🇰🇷Bucheon, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, St.Vincent Hospital
🇰🇷Suwon, Gyeonggi-do, Korea, Republic of
The Catholic University of Korea, Uijeongbu St. Mary'S Hospital
🇰🇷Uijeongbu, Gyeonggi-do, Korea, Republic of
dongguk university MEDICAL CENTER
🇰🇷Kyungju, Kyoung-Book, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Korea University Ansan Hospital🇰🇷Ansan, Gyeonggi-Do, Korea, Republic of